510(k) Report

FDA applicant

Agilent Technologies, Inc.

Andover, MA51 decisions1982–202519 recalls

FDA records 51 decisions for Agilent Technologies, Inc. (Andover, MA) from 1982 to 2025: 45 510(k) clearances and 6 original PMA approvals. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 24 predicates, 5 of them its own earlier devices. 19 recalls are linked to its devices.

FDA’s records also spell it “Agilent Technologies”, “Agilent Technologies, GmbH”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Agilent Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 22017: 12021: 12024: 12025: 1
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12010: 102020: 12025: 1
2007high 10 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Agilent Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Agilent Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Agilent”

FDA records each applicant name separately; these may or may not be the same firm.